UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021426 |
|---|---|
| Receipt number | R000024200 |
| Scientific Title | Angiogenic Therapy Against Peripheral Arterial Disease with bone marrow derived MSC grown in platelet-rich plasma |
| Date of disclosure of the study information | 2016/03/14 |
| Last modified on | 2018/09/21 11:46:30 |
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Basic information
Public title
Angiogenic Therapy Against Peripheral Arterial Disease with bone marrow derived MSC grown in platelet-rich plasma
Acronym
ATPAD
Scientific Title
Angiogenic Therapy Against Peripheral Arterial Disease with bone marrow derived MSC grown in platelet-rich plasma
Scientific Title:Acronym
ATPAD
Region
| Japan |
Condition
Condition
Peripheral arterial disease
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess safety of angiogenic therapy against peripheral arterial disease with bone marrow derived mesenchymal stem cell grown in platelet-rich plasma
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the frequency of occurrence of the adverse event of grade 2 or more on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 during 1 year after post treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Injection 0.3 to 0.5 ml cultivated bone marrow cell from about 1.0 x 107-8 as total volume about 10 to 50 ml of suspending liquid to muscle of ischemic leg using 27G needle.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
>= grade III of Fontain's classification,
>= grade II-4 of Rutherford's Classification
Key exclusion criteria
* The patient with remarkable short life expectancy
* Patient with the past which is alcohol or drug dependence within 3 months of past
* Patient with malignant neoplasms and the patient who has the past within 5 years
* The patient who judged that there was a possibility of the malignant tumor
* Patient with severe diabetic retinopathy
* The patient who can't get informed consent
* The patient who judged that he was unsuitable to this trial
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoji Fukuda |
Organization
National Center for Global Health and Medicine
Division name
Department of Cardiovascular Surgery
Zip code
Address
1-21-1 Toyama, Shinjuku, Tokyo 162-8655
TEL
03-3202-7181
sfukuda@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kanae Endo |
Organization
National Center for Global Health and Medicine
Division name
Department of Cardiovascular Surgery
Zip code
Address
1-21-1 Toyama, Shinjuku, Tokyo 162-8655
TEL
03-3202-7181
Homepage URL
http://www.hosp.ncgm.go.jp/s023/200/index.html
shinzou.gimu@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
RM27-003
Org. issuing International ID_1
NA8140003
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2016 | Year | 01 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Registration 6
Complete 5
Management information
Registered date
| 2016 | Year | 03 | Month | 10 | Day |
Last modified on
| 2018 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024200
